A Phase IV Multicenter, Open-Label Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy (MINORE)

  • STATUS
    Recruiting
  • End date
    Jan 22, 2024
  • participants needed
    44
  • sponsor
    Hoffmann-La Roche
Updated on 19 September 2022
clinically isolated syndrome
ocrelizumab

Summary

This study will evaluate the potential placental transfer of ocrelizumab in women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) [in line with the locally approved indications] whose last dose of ocrelizumab was administered any time from 6 months before the last menstrual period (LMP) through to the first trimester (up to gestational week 13) of pregnancy, and the corresponding pharmacodynamic effects (B cell levels) in the infant.

Details
Condition Multiple Sclerosis, Clinically Isolated Syndrome
Treatment Ocrelizumab
Clinical Study IdentifierNCT04998812
SponsorHoffmann-La Roche
Last Modified on19 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of MS or CIS (in line with the locally approved indications)
Currently pregnant with singleton pregnancy at gestational week ≤26 at enrolment
Documentation that first and second obstetric ultrasound has been conducted before enrolment during the screening period
Documentation that the last exposure to ocrelizumab occurred up to 6 months before the LMP before the woman became pregnant OR during the first trimester of pregnancy

Exclusion Criteria

Last exposure to ocrelizumab >6 months before the woman's LMP or later than the first trimester of pregnancy
Gestational age at enrolment >26 weeks
Non-singleton pregnancy
Received the last dose of ocrelizumab at a different posology other than per the local prescribing information
Lack of access to ultrasound pre-natal care as part of standard clinical practice
Prior or current obstetric/gynecological conditions associated with adverse pregnancy outcomes
Pre-pregnancy body mass index >35 kg/m2
Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
Prior or current history of primary or secondary immunodeficiency, or woman in an otherwise severely immunocompromised state
Significant and uncontrolled disease that may preclude a woman from participating in the study
Women with known active malignancies or being actively monitored for recurrence of malignancy including solid tumors and hematological malignancies
Prior or current history of alcohol or drug abuse, or current use of tobacco
Positive screening tests for hepatitis B
Treatment with drugs known to have teratogenic effects
Planned treatment with interferons, glatiramer acetate, or pulsed corticosteroids as a bridging therapy after the last ocrelizumab dose and throughout pregnancy
Treatment with disease-modifying therapies for MS within their respective half-lives prior to the last ocrelizumab dose or prior to the LMP
Treatment with teriflunomide within the last two years, unless measured plasma concentrations are <0.02 mg/L. If levels are >0.02 mg/L or not known, an accelerated elimination procedure is required
Treatment with any investigational agent within 6 months or five half-lives of the investigational drug prior to the last ocrelizumab dose or prior to the LMP
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